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Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
FDA product code DBA · Class 2 · Immunology
7
Registered devices
0
Adverse events
1
Recalls
13
510(k) clearances
Devices with this code
DImension Vista® C1 Inhibitor Flex® Reagent Cartridge — Siemens Healthcare Diagnostics Products GmbHAntiserum to Human C1 Esterase Inhibitor — KENT LABORATORIES INCHuman C1 Inactivator Kit for use on SPAPLUS — THE BINDING SITE GROUP LIMITEDMicroVue — QUIDEL CORPORATIONN Antiserum to Human C1-Inhibitor — Siemens Healthcare Diagnostics Products GmbHOptilite C1 Inactivator Kit — THE BINDING SITE GROUP LIMITEDHuman C1 Inactivator BINDARID™ Radial Immunodiffusion Kit — THE BINDING SITE GROUP LIMITED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-02-01 | Quidel Corporation | Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert |
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